Qsymia

Weight Management in Adults

Qsymia is indicated for chronic weight management in adults who have a body mass index (BMI) that meets specific criteria:

• Obesity: A BMI of 30 kg/m² or greater.
• Overweight: A BMI of 27 kg/m² or greater, when accompanied by at least one weight-related medical condition.

Weight-related medical conditions may include high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

Weight Management in Children

This medication is also approved for use in pediatric patients aged 12 years and older. It is prescribed for children who are considered obese, defined as having a BMI in the 95th percentile or higher for their specific age and sex.

Lifestyle Integration

Qsymia is intended to be used as part of a comprehensive weight-loss plan. It is not meant to be used alone and is typically prescribed alongside:

• A reduced-calorie diet.
• A consistent exercise program or increased physical activity.

Healthcare providers typically prescribe this medication to help patients achieve and maintain a healthier weight when lifestyle changes alone have not been sufficient to reach health goals.

Mechanism of Action

Qsymia is a combination of two different medications: phentermine and topiramate. These drugs work through different mechanisms in the central nervous system to assist with weight management.

Phentermine

Phentermine is a sympathomimetic amine, which is a type of stimulant. It works by stimulating the release of norepinephrine in the brain. This chemical signal helps suppress the appetite, making you feel less hungry throughout the day.

Topiramate

Topiramate is an anticonvulsant medication. While the exact way it contributes to weight loss is not entirely clear, researchers believe it works by:

• Increasing the feeling of being full (satiety).
• Making foods taste less appealing to some people.
• Increasing the amount of energy the body uses.

Together, these two components help reduce the overall amount of food a person eats, making it easier to follow a reduced-calorie diet and increase physical activity.

Common Side Effects

Many people using this medication experience mild side effects. These may include:

• Tingling or "pins and needles" sensations in the hands, arms, feet, or face
• Dizziness
• Changes in how food tastes, such as a metallic taste
• Insomnia or trouble sleeping
• Constipation
• Dry mouth

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Vision problems: Sudden decrease in vision, eye pain, or redness, which may indicate glaucoma.
• Mood and cognitive changes: New or worsening depression, anxiety, suicidal thoughts, confusion, or difficulty concentrating.
• Heart issues: A racing or pounding heartbeat while at rest.
• Metabolic acidosis: Symptoms may include hyperventilation, fatigue, or loss of appetite.
• Kidney stones: Severe pain in the back or side, or blood in the urine.
• Low potassium: Muscle spasms or abnormal heart rhythms.

In pediatric patients aged 12 and older, additional side effects such as joint pain, fever, flu-like symptoms, and headache have been reported. This medication also carries a high risk of birth defects if taken during pregnancy.

Pregnancy and Birth Defects

Qsymia can cause serious birth defects, specifically cleft lip or cleft palate, if taken during pregnancy. It is contraindicated in pregnant individuals. Healthcare providers typically require a negative pregnancy test before starting treatment and monthly tests thereafter. Effective contraception must be used consistently during treatment.

Heart Rate Monitoring

This medication can increase resting heart rate. Regular monitoring of the heart rate is recommended, especially when starting the drug or increasing the dose. Patients who experience a racing or pounding heartbeat while at rest should notify their healthcare provider.

Suicidal Thoughts and Behavior

Like other medications containing topiramate, Qsymia may increase the risk of suicidal thoughts or actions. It is important to monitor for any new or worsening depression, anxiety, or unusual changes in mood or behavior.

Vision Problems

Qsymia may cause acute myopia (nearsightedness) and secondary angle-closure glaucoma. Symptoms include a sudden decrease in vision or eye pain. If these occur, medical attention is needed immediately to prevent permanent vision loss.

Cognitive and Sleep Disturbances

Some people experience cognitive impairment, such as confusion, difficulty concentrating, or memory problems. Mood disorders and insomnia are also common. Because it can cause dizziness or tiredness, caution is advised when operating machinery or driving.

Metabolic and Kidney Concerns

• Metabolic Acidosis: Qsymia can lower bicarbonate levels in the blood, which may lead to metabolic acidosis. This can affect bone health or increase the risk of kidney stones.
• Kidney Stones: There is an increased risk of developing kidney stones. Staying well-hydrated is often recommended to help reduce this risk.
• Kidney and Liver Function: Dose adjustments may be necessary for individuals with moderate to severe kidney or liver impairment.

Stopping Treatment

Treatment should not be stopped suddenly. Abruptly discontinuing Qsymia can trigger seizures, even in patients without a history of epilepsy. A gradual reduction in dose is usually required to safely stop the medication.

Pregnancy Risks

Qsymia can cause serious harm to an unborn baby. One of its active ingredients, topiramate, significantly increases the risk of oral clefts (cleft lip or cleft palate) if a fetus is exposed during the first trimester of pregnancy. Because weight loss offers no potential benefit to a pregnant person and may cause fetal harm, this medication is contraindicated during pregnancy.

Requirements for Use

Due to the risk of birth defects, Qsymia is only available through a restricted program. Healthcare providers typically require the following for individuals who can become pregnant:

• Pregnancy Testing: A negative pregnancy test must be confirmed before starting treatment and then every month during treatment.
• Contraception: Effective birth control must be used consistently while taking the medication.

If you suspect you are pregnant or have a positive pregnancy test, you should stop taking Qsymia immediately and contact your healthcare provider.

Breastfeeding

It is not recommended to breastfeed while taking Qsymia. Both phentermine and topiramate can pass into breast milk. There is a potential for serious side effects in a nursing infant exposed to these medications. Patients should discuss alternative options with their healthcare provider to determine the safest course of action for both the parent and the child.

Available Forms

Qsymia is provided in the following form:

• Extended-release capsules: These capsules are designed to be taken by mouth. They contain a combination of two active ingredients that are released gradually after ingestion.

The capsules are intended to be swallowed whole. Breaking, crushing, or chewing the capsules can interfere with how the medication is released into the system.

FDA Approval and Indications

The FDA approved Qsymia (phentermine and topiramate extended-release) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management. It is indicated for the following groups:

• Adults with an initial body mass index (BMI) of 30 kg/m² or greater (obese).
• Adults with a BMI of 27 kg/m² or greater (overweight) who have at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol.
• Pediatric patients aged 12 years and older with a BMI in the 95th percentile or greater for their age and sex.

Risk Evaluation and Mitigation Strategy (REMS)

Because topiramate, one of the active ingredients in Qsymia, increases the risk of birth defects (specifically orofacial clefts) if taken during pregnancy, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS). This program is designed to inform healthcare providers and patients of reproductive potential about the need for monthly pregnancy testing and the use of effective contraception while taking the medication.

Regulatory Classification

Qsymia contains phentermine, which is classified by the Drug Enforcement Administration (DEA) as a Schedule IV controlled substance. This classification is due to the potential for misuse or dependence. Regulatory guidelines require specific record-keeping and limit how the prescription can be refilled.

Safety Warnings

The FDA has issued warnings regarding several serious risks associated with Qsymia, including suicidal thoughts or actions, acute myopia (nearsightedness), and secondary angle-closure glaucoma. Patients are advised to monitor for changes in mood or vision and to seek immediate medical attention if these symptoms occur.

How Qsymia Works for Weight Loss

Qsymia contains two active ingredients, phentermine and topiramate, that work together to promote weight loss. Phentermine is an appetite suppressant that belongs to a class of drugs called sympathomimetic amines. It works by triggering the release of chemicals in the brain that help reduce hunger. Topiramate is an anti-seizure medication that helps weight loss by increasing the feeling of fullness and making foods taste less appealing to some people.

Who Can Use Qsymia

This medication is approved for chronic weight management in the following groups:

• Adults: Those with a body mass index (BMI) of 30 or higher (obese), or a BMI of 27 or higher (overweight) who also have at least one weight-related medical condition, such as high blood pressure, type 2 diabetes, or high cholesterol.
• Pediatric Patients: Children aged 12 years and older who have a BMI in the 95th percentile or higher for their age and sex.

Usage and Lifestyle

Qsymia is intended for long-term use but must be combined with lifestyle changes to be effective. This includes following a reduced-calorie diet and maintaining a regular exercise program. Healthcare providers typically monitor progress closely; if a specific amount of weight loss is not achieved within the first few months, the dosage may be adjusted or the medication may be discontinued.